Interobserver Variation in Applying a Radiographic Definition for Acute Respiratory Distress Syndrome (ARDS)
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|ClinicalTrials.gov Identifier: NCT01704066|
Recruitment Status : Completed
First Posted : October 11, 2012
Last Update Posted : December 21, 2012
The original American-European Consensus Conference (AECC) definition of Acute Respiratory Distress Syndrome (ARDS) required bilateral infiltrates consistent with pulmonary edema on frontal chest X-ray (CXR), but there is poor inter-observer reliability in interpreting CXR using this definition among intensivists and radiologists.
As a result, the newly published Berlin definition of ARDS specified that the CXR criterion should include bilateral opacities consistent with pulmonary edema not fully explained by effusions, lobar/lung collapse, or nodules/masses on CXR.
In order to improve inter-observer agreement, the panel have also developed a set of CXRs judged as consistent, inconsistent, or equivocal for the diagnosis of ARDS.
The objective of this study is to investigate the impact of this training set on inter-observer reliability in applying the radiographic definition for ARDS.
|Condition or disease||Intervention/treatment|
|Acute Respiratory Distress Syndrome||Other: Training and education|
The study is composed of 3 phases:
Phase 1: All participants will be required to independently interpret a set of 12 CXRs, as provided by the consensus panel. The possible radiographic interpretations include consistent, inconsistent, or equivocal for the diagnosis of ARDS.
Phase 2: Training materials adapted according to the recently published Berlin definition of ARDS, with its expanded rationale and interpretation of all 12 CXRs, will be sent to all participants.
Phase 3: The same set of 12 CXRs, in different order, will be sent to all participants for interpretation for the second time.
|Study Type :||Observational|
|Actual Enrollment :||286 participants|
|Official Title:||Interobserver Variation in Applying a Radiographic Definition for ARDS: Impact of a Training Set of Berlin ARDS Definition|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
- inter-observer agreement in the interpretation of CXRs for the diagnosis of ARDS [ Time Frame: immediately after reading the CXRs ]
- Impact of the training set on the inter-observer agreement on the interpretation of CXRs [ Time Frame: difference of inter-observer agreement before and after the training course ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01704066
|Peking Union Medical College Hospital|
|Beijing, Beijing, China, 100730|
|Principal Investigator:||Bin Du, MD||Peking Union Medical College Hospital|